Search by Drug Name or NDC

    NDC 36800-0297-04 Cough and Runny Nose 160; 1; 5 mg/5mL; mg/5mL; mg/5mL Details

    Cough and Runny Nose 160; 1; 5 mg/5mL; mg/5mL; mg/5mL

    Cough and Runny Nose is a ORAL SUSPENSION in the HUMAN OTC DRUG category. It is labeled and distributed by TOP CARE (Topco Associates LLC). The primary component is ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE.

    Product Information

    NDC 36800-0297
    Product ID 36800-297_8875a1f7-fffc-4041-81c6-a9717eb7325a
    Associated GPIs
    GCN Sequence Number n/a
    GCN Sequence Number Description n/a
    HIC3 n/a
    HIC3 Description n/a
    GCN n/a
    HICL Sequence Number n/a
    HICL Sequence Number Description n/a
    Brand/Generic n/a
    Proprietary Name Cough and Runny Nose
    Proprietary Name Suffix Childrens Plus
    Non-Proprietary Name Acetaminophen, Chlorpheniramine maleate, Dextromethorphan hydrobromide
    Product Type HUMAN OTC DRUG
    Dosage Form SUSPENSION
    Route ORAL
    Active Ingredient Strength 160; 1; 5
    Active Ingredient Units mg/5mL; mg/5mL; mg/5mL
    Substance Name ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
    Labeler Name TOP CARE (Topco Associates LLC)
    Pharmaceutical Class Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
    DEA Schedule n/a
    Marketing Category OTC MONOGRAPH FINAL
    Application Number part341
    Listing Certified Through 2024-12-31

    Package

    NDC 36800-0297-04 (36800029704)

    NDC Package Code 36800-297-04
    Billing NDC 36800029704
    Package 1 BOTTLE, PLASTIC in 1 BOX (36800-297-04) / 118 mL in 1 BOTTLE, PLASTIC
    Marketing Start Date 2015-12-31
    NDC Exclude Flag N
    Pricing Information N/A